NCT00097097

Brief Summary

Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2004

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

First QC Date

November 17, 2004

Last Update Submit

July 29, 2014

Conditions

Asphyxia NeonatorumNeonatal MortalityHypoxic Ischemic Encephalopathy

Keywords

AsphyxiaNeonatal mortalityNeonatal morbidityHypoxic ischemic encephalopathyNeurodevelopmental impairmentNeonatal resuscitationGlobal NetworkZambiaAfricaCerebral palsyChild healthInternational

Outcome Measures

Primary Outcomes (1)

  • Neonatal mortality at 7 days

Secondary Outcomes (3)

  • Neonatal mortality due to perinatal asphyxia

  • Self efficacy, knowledge, performance, and competence in neonatal resuscitation

  • Apgar scores at 5 minutes

Interventions

Neonatal ResuscitationPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Live birth infants with birth weight ≥ 1500 g
  • Infants who are born at participating health centers in Lusaka and Ndola, Zambia
  • No lethal malformations

You may not qualify if:

  • Stillbirths
  • Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left sided congenital heart disease that will not be repaired)
  • Any infant who is transported/brought to the center after delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zambia

Lusaka, Zambia

Location

Related Links

MeSH Terms

Conditions

Asphyxia NeonatorumHypoxia-Ischemia, BrainAsphyxiaCerebral Palsy

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDeathPathologic ProcessesWounds and InjuriesBrain Damage, Chronic

Study Officials

  • Waldemar A Carlo, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Elwyn Chomba, MBChB, DCH, MRCP

    University Teaching Hospital, Lusaka, Zambia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2004

First Posted

November 18, 2004

Study Start

October 1, 2004

Study Completion

November 1, 2006

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

ZA(1)